Hearing Loss, SensorineuralNCT05043207
A Study Protocol for the Validation of UAud in a Clinical Setting.
A study testing uAud and Traditional audiometry in people with Hearing Loss, Sensorineural and Hearing Impairment, Sensorineural, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Impairment, Sensorineural
- What is being tested?
- uAud and Traditional audiometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz.
- Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL.
- Danish native speaker.
- No previous experience with HAs.
- Capable of answering questionnaires through an online mailbox.
Who cannot join
- Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies.
- Treatment affected by conductive hearing loss (air-bone gap >10 dB on more than one frequency below 1 kHz).
- Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs.
- Ear, nose, or throat surgery in the past 12 months.
- Evidence that the participant has made minor use of the HAs during the study (e.g., < 2h per day).
- Visual or motor impairment that might affect the use of the UAud system.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Southern Denmark
Odense, Funen, 5000
Carl Pedersen, Master's, 31314965, Carlp25@gmail.com
Carlp25@gmail.com
About this study
Official title: A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.
The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.
Read the detailed description
The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination.
Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.
- Being tested
- uAud, Traditional audiometry
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uAudDiagnostic test
Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
Traditional audiometryDiagnostic test
Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure
| Study group | Role | What they receive |
|---|---|---|
| uAud | Experimental | Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry. Receives: Diagnostic Test: uAud |
| control | Active comparator | Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry. Receives: Diagnostic Test: Traditional audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSQ12 (Speech, Spatial & Qualities of Hearing scale)
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.
Measured: 3 months
Secondary outcomes (1)
HINT (Hearing In Noise Test)
A performance test of patients speech intelligibility in noise.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, William Demant Fonden
- Responsible party
- Sponsor
- Investigators
- Jesper Hvass Schmidt, PhD, Principal investigator, SDU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043207
- Sponsor's protocol ID
- UAUD
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is governed by the hospital's GPDR (General Data Protection Regulation) agreements.
Publications
Pedersen C, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Schmidt JH. Comparison of hearing-aid effectiveness based on user-operated versus traditional audiometry: a randomised clinical trial. Int J Audiol. 2026 Feb;65(2):176-183. doi: 10.1080/14992027.2024.2434897. Epub 2024 Dec 2.
PubMed 39620470Pedersen CC, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Sidiras C, Pedersen RG, Schmidt JH. Comparison of hearing aid fitting effectiveness with audiograms from either user-operated or traditional audiometry in a clinical setting: a study protocol for a blinded non-inferiority randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e065777. doi: 10.1136/bmjopen-2022-065777.
PubMed 36863737
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05043207
- Acronym / sponsor ID
- UAUD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, William Demant Fonden
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.
Detailed description
The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination.
Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomised control trial
| Arm | Type | Receives |
|---|---|---|
| uAud | Experimental | Diagnostic Test: uAudPatients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry. |
| control | Active comparator | Diagnostic Test: Traditional audiometryPatients which hearing aid is fitted based on the audiometry obtained with traditional audiometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz.
- Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL.
- Danish native speaker.
- No previous experience with HAs.
- Capable of answering questionnaires through an online mailbox.
Key exclusion criteria (6 listed)
- Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies.
- Treatment affected by conductive hearing loss (air-bone gap >10 dB on more than one frequency below 1 kHz).
- Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs.
- Ear, nose, or throat surgery in the past 12 months.
- Evidence that the participant has made minor use of the HAs during the study (e.g., < 2h per day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uAudPatients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure | Diagnostic test | uAud |
| Traditional audiometryPatients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure | Diagnostic test | control |
Primary outcome
SSQ12 (Speech, Spatial & Qualities of Hearing scale)
Time frame: 3 months
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.
1 secondary outcome
HINT (Hearing In Noise Test)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 39620470Pedersen C, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Schmidt JH. Comparison of hearing-aid effectiveness based on user-operated versus traditional audiometry: a randomised clinical trial. Int J Audiol. 2026 Feb;65(2):176-183. doi: 10.1080/14992027.2024.2434897. Epub 2024 Dec 2.
- Derived from this study: PubMed 36863737Pedersen CC, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Sidiras C, Pedersen RG, Schmidt JH. Comparison of hearing aid fitting effectiveness with audiograms from either user-operated or traditional audiometry in a clinical setting: a study protocol for a blinded non-inferiority randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e065777. doi: 10.1136/bmjopen-2022-065777.
- Individual participant dataSharing planned: No. Data is governed by the hospital's GPDR (General Data Protection Regulation) agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Hvass Schmidt, PhD principal investigator
SDU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uAud and Traditional audiometry in people with Hearing Loss, Sensorineural and Hearing Impairment, Sensorineural, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl Pedersen, master's degree (+4531314965, pede@sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSQ12 (Speech, Spatial & Qualities of Hearing scale) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.